Blenoxane

NDA 50443, held by Bristol Myers Squibb. Bleomycin Sulfate.

As of Nov 13, 2026, NDA 50443 (Blenoxane), held by Bristol Myers Squibb, was first approved by FDA on Jul 31, 1973, with 31 approved supplements and 0 published complete response letters.

First approved: Jul 31, 1973
Supplements approved: 31
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 32 submissions below

Date	Submission	Status	Documents
Feb 20, 1996	Supplement 25Efficacy (new indication or use) · Standard review	Approved	None posted
Jul 31, 1973	Original applicationNew molecular entity	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
BlenoxaneEQ 15 UNITS BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Bleomycin Sulfate	DiscontinuedReference drug
BlenoxaneEQ 30 UNITS BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Bleomycin Sulfate	DiscontinuedReference drug

All 32 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 10, 2010	Supplement 36Labeling · Standard review	Approved	Review Letter Label
Jun 30, 2004	Supplement 27Labeling · Standard review	Approved	Letter
Mar 21, 2003	Supplement 35Labeling · Standard review	Approved	Label Letter
Mar 20, 2002	Supplement 33Manufacturing	Approved	None posted
Jul 3, 2000	Supplement 32Manufacturing	Approved	None posted
Jul 3, 2000	Supplement 30Manufacturing	Approved	None posted
Apr 12, 2000	Supplement 31Manufacturing	Approved	None posted
Oct 20, 1999	Supplement 29Labeling · Standard review	Approved	None posted
Aug 25, 1999	Supplement 28Labeling · Standard review	Approved	None posted
Sep 30, 1996	Supplement 26Manufacturing	Approved	Review
Feb 20, 1996	Supplement 25Efficacy (new indication or use) · Standard review	Approved	None posted
Sep 7, 1995	Supplement 24Manufacturing	Approved	None posted
Jan 21, 1994	Supplement 22Manufacturing	Approved	None posted
Jan 21, 1994	Supplement 21Manufacturing	Approved	None posted
Jan 21, 1994	Supplement 19Manufacturing	Approved	None posted
Jan 21, 1994	Supplement 17Manufacturing	Approved	None posted
Feb 23, 1993	Supplement 23Labeling · Standard review	Approved	None posted
Jan 30, 1991	Supplement 20Manufacturing	Approved	None posted
Oct 21, 1983	Supplement 14Manufacturing	Approved	None posted
Oct 19, 1983	Supplement 13Manufacturing	Approved	None posted
Sep 26, 1983	Supplement 12Manufacturing	Approved	None posted
Apr 13, 1983	Supplement 11Labeling	Approved	None posted
Dec 13, 1982	Supplement 10Manufacturing	Approved	None posted
Dec 21, 1976	Supplement 9Labeling	Approved	None posted
Apr 5, 1976	Supplement 5Manufacturing	Approved	None posted
Mar 31, 1976	Supplement 7Manufacturing	Approved	None posted
Mar 15, 1976	Supplement 8Labeling	Approved	None posted
Oct 10, 1975	Supplement 6Manufacturing	Approved	None posted
Oct 8, 1975	Supplement 4Labeling	Approved	None posted
Mar 5, 1975	Supplement 3Manufacturing	Approved	None posted
Aug 9, 1974	Supplement 2Labeling	Approved	None posted
Jul 31, 1973	Original applicationNew molecular entity	Approved	None posted

Identifiers

Application: NDA 50443
Drugs@FDA: Overview at FDA
Company: Bristol-Myers Squibb

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters